IL- 6 Gene (174G/C) Single Nucleotide Polymorphism as an Indicator of COVID-19 Severity in Egyptian Patients

Sponsor
Tanta University (Other)
Overall Status
Completed
CT.gov ID
NCT04544033
Collaborator
(none)
120
1
19.5
6.2

Study Details

Study Description

Brief Summary

Although the direct damage from the viruses contributes to the initiation of the disease, the cytokine storm caused by COVID-19 plays a vital role in the development of acute lung injury and adult respiratory distress syndrome. IL-6, a kind of pleiotropic cytokine, is expressed by immune cells such as DC, monocytes, macrophages, B cells, and subsets of activated T cells, as well as by non-immune cells like fibroblasts, epithelial cells, and keratinocytes

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: interleuken 6 level measurment
  • Diagnostic Test: Interleukin-6 Gene-174C detection

Detailed Description

The World Health Organization (WHO) declared coronavirus disease 2019 (COVID-19) a public health emergency of international concern the epidemic has put public health systems under severe strain both in western countries and in the developing world. SARS-CoV-2 displays a more efficient transmission pattern when compared with SARS-CoV and MERS-CoV. Although the direct damage from the viruses contributes to the initiation of the disease, the cytokine storm caused by COVID-19 plays a vital role in the development of acute lung injury and adult respiratory distress syndrome.

IL-6, a kind of pleiotropic cytokine, is expressed by immune cells such as DC, monocytes, macrophages, B cells, and subsets of activated T cells, as well as by non-immune cells like fibroblasts, epithelial cells, and keratinocytes. It contributes to the pathogenesis of inflammatory or autoimmunity diseases. Excessive production of IL-6 leads to serious disease progression in viral infection. The IL-6 gene is located on chromosome 7 and several polymorphisms have been reported. The most frequently studied polymorphism is the single nucleotide polymorphism (SNP) 174C and - 174G in the promoter region, which has been associated with transcription rates of IL6. The incidence of IL-6-174C alleles is approximately 40%among the general Population. The G allele 174 SNP is coupled with the increased transcription upon endotoxin and IL-1β stimulation, IL-6 -174C allele carrier status is associated with higher level of IL-6 production and more severe forms of 4 pneumonia in general. This analysis strengthens the notion that IL-6 plays a pivotal role in novel coronavirus pneumonia (NCP) progression, it was IL-6-174 C allele rather than G allele that contributed to the risk of sepsis induced by Pneumonia

Study Design

Study Type:
Observational
Actual Enrollment :
120 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
IL- 6 Gene (174G/C) Single Nucleotide Polymorphism as an Indicator of COVID-19 Severity in Egyptian Patients
Actual Study Start Date :
Sep 15, 2020
Actual Primary Completion Date :
Mar 15, 2022
Actual Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
mild group

Amendment to MOH COVID-19 Protocol: Patient with mild clinical symptoms & clinically table. CT changes: Appearance in the lung from no changes to just subpleural nodule or subpleural line.

Diagnostic Test: interleuken 6 level measurment
Detection of IL6 level using ELISA technique.

Diagnostic Test: Interleukin-6 Gene-174C detection
The genotyping of the polymorphisms in IL-6 promoter G-174C (rs1800795) will be performed using PCR-RFLP technique.

moderate group

Amendment to MOH COVID-19 Protocol: Patient with non-specific and specific respiratory infection (pneumonia). CT changes in both lungs (Ground glass opacities (GGO), Crazy paving, consolidation, multiple interlobular thickening).

Diagnostic Test: interleuken 6 level measurment
Detection of IL6 level using ELISA technique.

Diagnostic Test: Interleukin-6 Gene-174C detection
The genotyping of the polymorphisms in IL-6 promoter G-174C (rs1800795) will be performed using PCR-RFLP technique.

severe group

Amendment to MOH COVID-19 Protocol: Patients with respiratory distress (RR > 30/min, Sa02 < 92 at room air). Chest radiology showing more than 50% lesion or progressive lesion within 24 to 48 hours. CT changes in both lungs: extensive (GGO, Crazy paving, consolidation, multiple interlobular thickening, fan shaped distribution of peribronchial thickening).

Diagnostic Test: interleuken 6 level measurment
Detection of IL6 level using ELISA technique.

Diagnostic Test: Interleukin-6 Gene-174C detection
The genotyping of the polymorphisms in IL-6 promoter G-174C (rs1800795) will be performed using PCR-RFLP technique.

Outcome Measures

Primary Outcome Measures

  1. interleuken- 6 gene (174G/C) single nucleotide polymorphism ["through study completion, an average of 4 months]

    the correlation between IL- 6 gene (174G/C) single nucleotide polymorphism with the pathogenesis of COVID-19 severity in Egyptian patients.

Secondary Outcome Measures

  1. interleukin 6 level ["through study completion, an average of 4 months]

    the correlation between IL-6 with the pathogenesis of COVID-19 severity in Egyptian patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients proved to be COVID-19 positive

  • clinical correlation with positive PCR.

  • clinical correlation with positive rapid antigen detection test.

Exclusion Criteria:
  • Patients with chronic infections including hepatitis B or C infection.

  • Immunodeficiency virus (HIV) infections.

  • Autoimmune diseases including systemic lupus erthromatosus and rheumatoid arthritis.

  • Any malignancy or chronic inflammation

  • Any other chest diseases (TB)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bsant Safwat Kasem Tanta El Gharbyia Egypt 31527

Sponsors and Collaborators

  • Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
bsant safwat kasem, principle investigator, Tanta University
ClinicalTrials.gov Identifier:
NCT04544033
Other Study ID Numbers:
  • IL6 in egyptian COVID patients
First Posted:
Sep 10, 2020
Last Update Posted:
May 3, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 3, 2022